WASHINGTON — Federal health officials appear to be leaning
toward lifting their recommended pause on the use of
Johnson & Johnson’s
coronavirus vaccine after finding only a limited number of additional cases of
a rare blood clotting disorder among recipients.
اضافة اعلان
Instead, the
Food and Drug Administration is likely to attach a
warning to the vaccine’s label to inform health practitioners — and the public
— about the exceedingly uncommon, but dangerous possible side effect.
Federal health officials are waiting to act until they hear from
a committee of outside experts who advise the
CDC. The committee is scheduled
to meet Friday to discuss whether to recommend lifting, extending or modifying
the pause that was initiated April 13.
“We know that it’s not a good thing to leave the pause going for
any longer than it absolutely has to go for,” Dr. Peter Marks, the Food and
Drug Administration’s top vaccine regulator, said Thursday, adding that a
protracted pause could contribute to greater vaccine hesitancy. “Once, essentially,
the adequate discussion has occurred, we’re prepared to move as quickly as we
possibly can.”
When top federal health officials abruptly decided early last
week to recommend a temporary halt in the use of the shot, six women had been
reported to have suffered from the disorder, a combination of clots in the
brain that led to bleeding and low platelets, components of the blood that
normally help to heal wounds.
That was fewer than 1 in 1 million recipients of Johnson &
Johnson’s shot in the United States. But officials worried that more cases were
hidden or could develop shortly as the new vaccine rolled out.
That fear has not materialized.
Marks and Dr. Janet Woodcock, the FDA’s acting commissioner,
said the clotting disorder appeared to be nearly as rare as they hoped it would
be when they recommended the pause.
“We’ve now received more cases, but it isn’t an avalanche,”
Woodcock said “We’re not seeing a big surge, which is a great relief.”
Marks declined to specify how many new cases had been confirmed,
but said the rate of the disorder was not expected to be higher “in terms of
the order of magnitude.”
Even if the CDC’s advisory committee decides Friday that the
benefits of Johnson & Johnson’s single-dose vaccine outweigh its risks, the
company will still face manufacturing hurdles at a Baltimore plant that
regulators have refused to certify. That plant was supposed to deliver the bulk
of the nearly 100 million doses the firm had promised to have ready by the end
of May.
But it would mean a temporary surge of about 10 million shots
that were effectively put on hold when the pause was announced. Some state
officials had been planned to use the one-dose, easily stored vaccine to
inoculate college students before the summer or for other transient or hard-to-reach
populations, but had to abruptly shelve those plans.
Dr. Rochelle P. Walensky, the CDC director, said in an interview
Wednesday that federal officials had found “needles in haystacks,” an
indication of how thorough the government’s oversight was. “We would like to
make a decision quickly after ACIP,” she said, using the acronym for the expert
panel called the Advisory Committee on Immunization Practices. “America and the
world are interested in moving forward.”
European regulators, presented with similar concerns,
recommended earlier this week that the vaccine’s rollout continue as long as a
warning is added to the product about the risks of the blood clotting disorder.
If U.S. officials follow suit, they will be reverting to a precaution that they
considered early on.
In the days before the pause was initiated, FDA officials had
drafted a brief warning about possible rare blood clots to attach to the
section of the vaccine’s emergency use authorization describing possible side
effects.
Doctors had prescribed the wrong treatment for several women who
received the vaccine and suffered the clotting disorder, possibly worsening
their conditions. With CDC input, officials expected that the unusual warning
for doctors about the need for specialized treatment and consultation could be
issued as early as April 13, according to people who heard about the planning.
But in an 8 p.m. meeting on April 12, the plans changed.
Walensky, Woodcock and other top health officials said they decided that a
temporary halt in the use of the vaccine would give doctors and federal
scientists more time to recognize and understand any possible link between the
vaccine and the clots.
Some federal health officials felt the move — one of most
consequential interventions the administration has made in its pandemic
response — was a hasty overreaction that at least temporarily withdrew a
valuable weapon in the middle of the nation’s vaccination campaign with little
evidence of a broad risk to Americans.
Just a day after his own agency recommended the pause, Dr. Doran
Fink, a key FDA vaccine regulator, suggested to the CDC’s advisory panel that
if doctors and recipients were given enough information, the vaccine could be
brought back into play while researchers continue to study the potential risk.
“Our current thinking is that this risk could be managed by
inclusion of warning statements,” Fink told other experts at the first advisory
meeting on April 14.
His remarks were unusually explicit, according to Dr. William
Schaffner, an infectious disease expert and a consultant to the panel. They
suggested the choice was not as obvious as the Biden administration presented
it last week.
In fact, the deliberations underscored how messy and uncertain
the work of crafting policy in the midst of public health emergency can be.
Scientists must make possibly life-or-death decisions while still gathering
data on tight deadlines.
Woodcock on Thursday acknowledged differences of opinion within
the FDA about the benefits of a temporary halt versus the risks of additional
coronavirus infections if the vaccine were temporarily shelved.
As European regulators, CDC and FDA officials grappled with
reports of the rare clotting cases in the weeks before the pause, regulators
saw an unmistakable similarity in the cases in the United States. All had
occurred within one to three weeks of vaccination and they were clustered in
women under age 50.
One woman in Virginia had died, and three others had been
hospitalized, two of them in intensive care.
Woodcock said that a warning would have been insufficient if
there was in fact a high rate of cases, like 1 in every 25,000 or 50,000 young
women. “We would be putting people at risk when we didn’t have that
information,” she said, and pushing ahead amid uncertainty “could actually
cause a worse reaction in the population.”
Some did express concern, given the daily number of new
infections and the number of Americans who may have been protected over the
past 10 days had the vaccine remained in use.
“It’s just very hard for me to see, even if you multiply the
number of cases by five or by 10 that you come to the conclusion that this is
not a good thing to do, giving you the vaccine,” said Dr. Ezekiel J. Emanuel, a
professor of medical ethics and health policy at the University of
Pennsylvania.
The decision to recommend the pause was “not cut and dry,”
Walensky allowed, but it had “overwhelming support within and outside the
agency.” She said the vaccine “was going to take a hit regardless given that we
had to put the warning on it.”
Dr. Anthony Fauci, the government’s top infectious disease
expert, said in an interview this week that his colleagues made the right call.
Public health emergencies often require charged policy choices with incomplete
data, he said.
“It’s so painful or difficult when there is not an absolutely
right or absolutely wrong way to come down on something. It’s just a gray
zone,” Fauci said, but “a decision has to be made.”
Inside the CDC’s Atlanta headquarters over the past week,
officials vetted and adjudicated an expected uptick in reports of clotting
incidents, Walensky said.
The CDC had also devised models to measure the effect of the
pause on people who might not get vaccinated without the Johnson & Johnson
shot available — a “risk-benefit at a population level” that aimed to help
scientists understand the “true value of that vaccine,” Walensky said.
Some early polling about the pause suggested that Americans saw
the move as a sign that the government was responsibly monitoring the vaccines,
while one released by Boston Children’s Hospital showed that Americans who want
to get vaccinated are now significantly less willing to get the Johnson &
Johnson shot.
“It took only six cases to do this,” said Dr. Joseph Kanter, the
top health official in Louisiana, where other vaccines had to be substituted
for Johnson & Johnson’s at homeless vaccination events in New Orleans, faith
organization vaccine drives and on college campuses. “Anyone who has questions
or concerns about how serious safety is taken should look at this as an example
that safety is paramount.”
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